Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

SPECTRUM COMPLETES PATIENT ENROLLMENT IN OZARELIX PHASE II TRIAL

Spectrum Pharmaceuticals has achieved complete enrollment for a Phase II trial
of ozarelix in benign prostatic hypertrophy (BPH), more that four months ahead
of schedule. The multicenter clinical trial is designed to evaluate both objective
parameters, such as improvement in urine flow and shrinkage of the prostate
volume, as well as various symptoms of BPH over a period of several months.
The trial is being conducted in Europe with the collaboration of AEterna Zentaris.

Ozarelix is a fourth-generation LHRH (luteinizing hormone releasing hormone),
also known as GnRH (gonadotropin releasing hormone), antagonist. LHRH antagonists
have the potential to treat hormone-dependent cancers as well as benign proliferative
disorders such as benign prostatic hypertrophy and endometriosis.